Novartis Consumer Health
Action And Clinical Pharmacology: Dextromethorphan is a centrally acting antitussive which is comparable to codeine on a mg basis for cough suppression but lacking analgesic or addictive properties.
Antitussive efficacy in adults is seen after 10 to 20 mg doses every 4 hours or 30 mg every 6 to 8 hours. With the usual therapeutic dosage, no effect has been noted on respiratory, cardiovascular or gastrointestinal function. Respiratory depression has been noted following ingestion of very large doses.
Dextromethorphan polistirex is a sustained-release preparation. Clinical bioavailability studies have shown that a single 60 mg dose provides plasma concentrations of dextromethorphan similar to those obtained with two 30 mg doses of dextromethorphan HBr given at 6 hour intervals. After repeated doses at steady state, equivalent plasma concentrations are maintained when Delsym is taken every 12 hours as compared to dextromethorphan HBr every 6 hours.
Indications: For the temporary relief of cough due to minor throat and bronchial irritation as may occur with the common cold or with inhaled irritants.
Manufacturers’ Warnings In Clinical States: Dextromethorphan should not be taken for persistent or chronic cough such as occurs with smoking, asthma or emphysema, or where cough is accompanied by excessive secretions, except under the advice and supervision of a physician.
Do not give this product to children under 2 years of age except under the advice and supervision of a physician.
Drug Interactions: Two fatalities have been reported following ingestion of dextromethorphan in patients treated with phenelzine. Do not use in patients receiving MAO inhibitors.
Pregnancy and Lactation: Do not administer to women who are pregnant or nursing unless, in the opinion of a physician, the potential benefits of the drug outweigh the possible risks.
Precautions: A persistent cough may be a sign of a serious condition. The patient should be advised to consult a physician if cough persists for more than 1 week or if cough tends to recur or is accompanied by high fever, rash or persistent headache.
Dependence Liability: Substitution studies in morphine addicts indicate that dextromethorphan is devoid of dependence liability. Intoxication and bizarre behavior have occurred after ingestion of 300 to 1 500 mg several times daily.
Adverse Reactions: Rarely, drowsiness, dizziness, headache, nausea or vomiting may occur.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: Respiratory depression has been noted with very large doses. Ataxia and hyperactivity have also been reported following ingestion of 360 mg of dextromethorphan HBr in a 22-month old child. Administration of 5 Âµg/kg naloxone HCl i.v. produced rapid resolution of ataxia. tag_DosageDosage
Dosage And Administration: Shake well before use.
Adults: 10 mL every 12 hours; do not exceed 20 mL in 24 hours.
Children: 6 to 12 years old: 5 mL every 12 hours; do not exceed 10 mL in 24 hours. 2 to 5 years old: 2.5 mL every 12 hours; do not exceed 5 mL in 24 hours. Under 2 years old: Use only under the advice of a physician.
Availability And Storage: Each 5 mL of controlled release suspension contains: dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide. Nonmedicinal ingredients: anhydrous citric acid, corn syrup, ethylcellulose, FD&C yellow #6, granulated sugar, gum tragacanth, methylparaben, orange flavor, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben, purified water, vegetable oil, xanthan gum. Energy: 27.6 kJ (6.6 kcal)/5 mL. Sodium:
DELSYM® Novartis Consumer Health Dextromethorphan Polistirex Antitussive